Fermion’s CDMO API services cover the needs of a customer from Phase I clinical studies until commercial production. We have extensive experience in NCE drug substance development and manufacturing since 1990’s. Currently there are about 10 originally new chemical entities wherein Fermion has had an important role during the development of the drug substance. These molecules are sold on the global market including USA, EU, Japan and China.
To secure timely completion of each critical phase of customer’s NCE project, we follow a carefully designed process with milestones and deliverables set for Phase I, II, and III, and for moving to commercial phase.
Phase I: Robust and safe process
Phase II: Target to select SMs, synthesis route and discrete parameters after PII campaigns.
Phase III: Optimization of process parameters (DoE as needed)
Commercial: Finalization of the process
Synthesis and process development
Phase I: Route suitability, Discrete parameters, Impurity control (organic, mutagenic) for API to meet specifications, Physical characteristics as needed
Phase II: Impurity studies continued, Physical characteristics, crystallizations & milling studies
Phase III: Critical parameters, NOR & PAR determination
Commercial: Process validation, Process life cycle management
Analytical method development
Phase I: Development of analytical methods for SMs, IMs and API; Validation of API analytical methods
Phase II: Development of analytical methods for SMs, IMs and API; Validation of API analytical methods
Phase III: Development of analytical methods for SMs, IMs and API; ICH level validation of API analytical methods
Commercial: Finalization and validation of analytical methods for SMs, IMs and API
Tasks applicable for all phases
- Setting appropriate specifications
- Safety studies
- Impurity profile
- Control strategy
- IND / IMPD and finally DS sections to NDA/MAA or separate DMF